An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

Breakthrough Pain Clinical Trial

Official title:

An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01901718
• Other study ID #: ICRI-Subsys-001
• Status: Terminated
• Phase: N/A
• First received: April 25, 2013
• Last updated: September 2, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: International Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Description:

Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age.

• Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days.

• Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment.

• Are able to follow and complete all necessary study procedures.

• Are willing and able to give written informed consent before participating in the study.

• Enrolled in the class wide REMS as verified by the study personnel.

Exclusion Criteria:

• Subjects who are not opioid tolerant.

• Using a rapid onset opioid other than Actiq® to manage their breakthrough pain.

• Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator.

• Are subjects with uncontrolled or rapidly escalating pain.

• Are subjects with a history of alcohol or substance abuse within the last 3 years.

• Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject.

• Are subjects who have participated in another clinical trial with an analgesic within the last month.

• Are female subjects with a positive pregnancy test or who are currently lactating.

• Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole.

• Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication.

• Opioid being used for chronic migraine or acute pain.

• Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Pain

Locations

Country	Name	City	State
United States	International Clinical Research Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
International Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimal Dose Calculation	Time to "optimal" dose of an open-label study medication in the Titration phase.	14 Days	No
Primary	Patient Global Impression of Change	The overall impression of change based on a patient's response to the Patient Global Impression of Change (PGIC) questionnaire at month 1, 2, and 3 or upon early discontinuation.	30, 60, 90 days	No
Secondary	Percent of Patients Satisfied with Treatment	Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied.	Baseline, 30, 60, 90 days	No
Secondary	Study Medication Ease of Use		Baseline, 30, 60, 90 days	No
Secondary	Quality of Life	Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life.	Baseline, 30, 60, 90 days	No
Secondary	Assessment of Sleep	Medical Outcomes Score (MOS) Sleep Subscale will be used to measures 6 dimensions of sleep and is a useful indicator of the efficacy of analgesic medications.	Baseline, 30, 60, 90 days	No
Secondary	Medication Dosing	Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.	Baseline	No
Secondary	Weight		Baseline, 30, 60, 90 days	No
Secondary	Blood Glucose	Blood will be drawn to measure HbA1c.	Baseline and 90 days	No